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WO 2009/132342 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 29 October 2009 (29.10.2009) WO 2009/132342 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 31/00 (2006.01) A61K 9/51 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 9/107 (2006.01) A61P 31/10 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, (21) International Application Number: EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, PCT/US2009/04181 1 HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, (22) International Filing Date: KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, 27 April 2009 (27.04.2009) MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, (25) Filing Language: English SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, (26) Publication Language: English UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/048,075 25 April 2008 (25.04.2008) US kind of regional protection available): ARIPO (BW, GH, 61/129,962 1 August 2008 (01 .08.2008) US GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, 61/1 15,879 18 November 2008 (18.1 1.2008) US ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, (71) Applicant (for all designated States except US): ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, NANOBIO CORPORATION [US/US]; 23 11 Green MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, TR), Road, Suite A, Ann Arbor, MI 48105 (US). OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). (72) Inventors; and (75) Inventors/Applicants (for US only): BAKER, James, R. Published: [US/US]; 3997 Holden Drive, Ann Arbor, MI 48103 — with international search report (Art. 21(3)) (US). FLACK, Mary, R. [US/US]; 3055 Geddes Av enue, Ann Arbor, MI 48 104 (US). CIOTTI, Marie [US/ — before the expiration of the time limit for amending the US]; 5908 Quebec Avenue, Ann Arbor, MI 48103 (US). claims and to be republished in the event of receipt of SUTCLIFFE, Joyce, A. [US/US]; 3575 Stanton Court, amendments (Rule 48.2(h)) Ann Arbor, MI 48 105 (US). (74) Agents: SIMKIN, Michele, M. et al; Foley & Lardner LLP, Washington Harbour, 3000 K St., NW, Sixth Floor, Washington, DC 20007 (US). (54) Title: NANOEMULSIONS FOR TREATING FUNGAL, YEAST AND MOLD INFECTIONS (57) Abstract: The present invention relates to methods for treating and completely curing fungal, yeast, and/or mold infections in human subjects comprising topically administering to a human subject in need thereof an antifungal nanoemulsion composition. NANOEMULSIONS FOR TREATING FUNGAL, YEAST AND MOLD INFECTIONS CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority of U.S. Provisional Patent Application No. 61/048,075, filed on April 25, 2008; U.S. Provisional Patent Application No. 61/129,962, filed on August 1, 2008; and U.S. Provisional Patent Application No. 61/1 15,879, filed on November 18, 2008, the disclosures of which are incorporated herein by reference in their entireties. FIELD OF INVENTION The present invention relates to methods for treating, killing, and/or inhibiting the growth of fungal, yeast, and mold pathogens in human subjects comprising topically administering to a human subject in need thereof a nanoemulsion composition having antifungal, anti-yeast, and/or anti-mold properties. The present invention also relates to methods for treating, preventing, and/or completely curing fungal, yeast, and/or mold infections in human subjects comprising topically administering to a human subject in need thereof a nanoemulsion composition having antifungal, anti-yeast, and/or anti-mold properties. BACKGROUND OF THE INVENTION A. Fungal/Yeast/Mold Infections Fungi cause a wide variety of diseases in humans. While some fungi cause infections limited to the outermost layers of the skin and hair (superficial mycoses), other fungi cause cutaneous mycoses by penetrating to the keratinized layers of the skin, hair and nails and triggering pathologic changes in the host. Subcutaneous mycoses cause infections in the dermis, subcutaneous tissues, muscle and fascia and are often chronic. Systemic mycoses originate primarily in the lung and may cause secondary infections in other organ systems in the body. Patients with immune system deficiencies are often prone to opportunistic mycoses. Dermatophytes, including Trichophyton rubrum and Trichophyton mentagrophytes, are responsible for fungal infections of the skin or Dermatophytoses (dermatophytose). Tinea pedis is a skin infection that most often manifests between the toes, causing scaling, flaking and itching of the affected skin. Blisters and cracked skin may also occur, leading to exposed raw tissue, erythema, pain, swelling and inflammation. A second type of tinea pedis is called the moccasin tinea pedis and is characterized by chronic plantar erythema with slight scaling to diffuse hyperkeratosis that can be asymptomatic or pruritic. Other types include inflammatory/vesicular and ulcerative tinea pedis. The infection can be spread to other areas of the body, and manifest itself in the form of annular scaly plaques with raised edges, pustules, and vesicles in the trunk and arms and legs {Tinea corporis), scaly rash in the palms and finger webs {Tinea manuum), erythematous lesions in the groin and pubic region {Tinea cruris), erythema, scaling, and pustules in the beard and neck area {Tinea barbae or Tinea faciale), or round, bald, scaly patches in the scalp {Tinea capitis). Tinea versicolor, also called pityriasis versicolor, is a common fungal infection of the skin that interferes with the normal pigmentation of the skin, resulting in small, discolored patches. Tinea unguium is another term for dermatophyte infections of the nail. Secondary bacterial infections may develop from the fungal infection. Tinea is very common, especially among children, and may be spread by skin-to-skin contact, as well as via contact with contaminated items such as hairbrushes or through the use of the same toilet seat as an infected individual. Tinea spreads readily, as those infected are contagious even before they show symptoms of the disease. Participants in contact sports such as wrestling have a risk of contracting the fungal infection through skin-to-skin contact. Tinea is mildly contagious. Tinea is also a common infection in domestic animals, especially farm animals, dogs and cats and even small pets like hamsters or guinea pigs. Humans can contract tinea (also commonly referred to as "ringworm") from these animals as humans are in close contact with them. Tinea can also be caught from other humans, both by direct contact and by prolonged contact with flakes of shed skin (from sharing clothes or from house dust, for instance). The best known sign of tinea in people is the appearance of one or more red raised itchy patches with defined edges, not unlike the herald rash of Pityriasis rosea. These patches are often lighter in the center, taking on the appearance of a ring with hyperpigmentation around the circumference caused by an increase in melanin. If the infected area involves the scalp or beard area, then bald patches may become evident. The affected area may become itchy for periods of time. Sometimes a tinea infection may cause skin lesions in a part of the body that is remote from the actual infection. Such lesions are called "dermatophytids". The lesions themselves are fungus-free, and normally disappear upon treatment of the actual infection. The most common example is an eruption in the hands resulting from a fungus infection of the feet. Dermatophytids are essentially a generalized allergic reaction to the fungus. Thus, fungi and yeast such as Microsporum species, Trichophyton species, Epidermophyton species, and Candida species can cause persistent and difficult to treat infections. Examples of Microsporum species include M. canis and M. gypseum. Microsporum is one of the several fungal genera that cause dermatophytosis. Dermatophytosis is a general term used to define the infection in hair, skin or nails due to any dermatophyte species. Similar to other dermatophytes, Microsporum has the ability to degrade keratin and thus can reside on skin and its appendages and remains noninvasive. Notably, Microsporum spp. mostly infect the hair and skin. Microsporum canis is the principal cause of ringworm in dogs and cats and a zoophilic fungal species causing sporadic dermatophytosis in humans, especially tinea capitis in children with cats and dogs. Skin infection by a Trichophyton species occurs mainly on the back of the neck, scalp or beard. Symptoms of a Trichophyton species infection include inflamed scalp lesions, inflamed neck lesions, inflamed beard lesions, scarring, and permanent hair loss. Examples of Trichophyton species include T. rubrum, T. tonsurans and T. mentagrophytes. Trichophyton tonsurans is an anthropophilic endothrix species of fungi that causes epidemic dermatophytosis in Europe, South America, and the U.S. It infects some animals and requires thiamine for growth. It is the most common cause of tinea capitis in the U.S., forming black dots where hair breaks off at the skin surface. Trichophyton rubrum is a fungus that is the most common cause of tinea pedis ("athlete's foot"), tinea cruris, and tinea (ringworm). Trichophyton rubum is the most common of the dermatophytes causing fingernail fungus infections. While most fungal skin infections are irritating and difficult to treat, there are reports of fungal infections resulting in death.
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